Universal dynamic athletic ankle brace and add-on interior stirrup support system

ABSTRACT

A rear-entry ankle brace includes an elastomeric component defining an inside elbow channel configured to span an ankle joint. A channel opening extends the length of the elastomeric component for direct insertion on top of a leg. One or more leg straps are used to adjustably tension first and second rear edges of the channel opening toward one another and secure the brace to the lower leg. Two foot straps are used to adjustably tension first and second bottom edges of the channel opening toward one another and secure the brace to the mid-foot. The foot straps overlap on the bottom to define a plantar surface of the brace and cross over each other on the topside of the elastomeric component and are secured to a leg strap. A pair of stabilizing stirrups optionally are included on the inside surfaces of the elastomeric component and receive the malleoli.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a U.S. nonprovisional patent application of,and claims priority under 35 U.S.C. § 120 to, U.S. provisional patentapplication 63/156,037, filed Mar. 3, 2021, incorporated by referenceherein.

COPYRIGHT STATEMENT

Any new and original work of authorship in this document-including thecomputer program listing—is subject to copyright protection under thecopyright laws of the United States and other countries. Reproduction byanyone of this document as it appears in official governmental recordsis permitted, but otherwise all other copyright rights whatsoever arereserved.

INCORPORATION OF COMPUTER PROGRAM LISTING APPENDIX

Submitted concurrently herewith via the USPTO's electronic filingsystem, and hereby incorporated herein by reference, is a computerprogram listing appendix representing computer program files includinginstructions, routines, and/or other contents of several computerprograms. A table setting forth the name and size of files included inthe computer program listing appendix is included below.

File Name Creation Date File Size (bytes) ascify.txt Mar. 3, 2022 21:4637,473 readme.txt Mar. 3, 2022 21:46 3,978 1319001.txt Mar. 3, 202221:46 24,968,835 1319002.txt Mar. 3, 2022 21:46 24,968,454 1319003.txtMar. 3, 2022 21:46 24,968,073 1319004.txt Mar. 3, 2022 21:46 9,411,226

One of these files, “readme.txt”, contains instructions for utilizing“ascify.txt” to convert the other ASCII files in this computer programlisting into a compressed “.zip” file. The compressed “.zip” fileresulting from “1319.txt” comprises: an interactive PDF file titled“BraceAssembly.pdf” for a three-dimensional rendering of a preferredembodiment of a rear-entry brace in accordance with aspects and featuresof the invention; three eDrawings illustrating the brace assembly andelastomeric component in accordance with aspects and features of theinvention; and a video illustrating a method of donning a preferredembodiment of a rear-entry brace in accordance with aspects and featuresof the invention. The .PDF file is compatible with the current releaseof Adobe Acrobat running in Microsoft Windows on a PC; the .EPRT filesare compatible with the current release of the free eDrawings viewerprogram available from Dassault Systemes Corporation running inMicrosoft Windows on a PC; and the .MOV file is compatible with WindowsMedia Player of Microsoft Windows on a PC.

BACKGROUND OF THE INVENTION

Joint sprains are a common occurrence and, in particular, ankle sprainsaccount for an estimated 2 million injuries per year in the UnitedStates alone. They occur in nearly all types of daily activities andsporting events and are the most common sports-related injury. Apractical method of decreasing the number and severity of these injurieswould clearly be of great benefit since ankle sprains result in a riskof further, and even more severe injury and lasting ankle problems, aswell as significant time away from games and practices. To this end,many people use prophylactic bracing or ankle taping as a means todecrease the risk of injury, including people who have suffered in thepast from a sprained ankle, or in instances where there may be anincreased tendency for injury, such as for joints that are subjected torigorous use or use in uneven terrain; however, while taping is commonlyviewed as effective, it is extremely labor intensive, is good for asingle use, and requires an educated application, all of which cause itto be very expensive. Rear-entry ankle braces in accordance with aspectsand feature of the present invention, which preferably are designed tobe worn under shoes, are believed to be an effective alternative to suchtaping. Moreover, these new and innovative aspects and features arebelieved to represent further improvements over applicant's other anklebraces as disclosed, for example, in U.S. patent application publicationnos. 2017/0135839; 2017/0367868; and 2020/0121486. For purposes of theUnited States, each of these application publications is incorporatedherein by reference.

SUMMARY OF THE INVENTION

The invention includes many aspects and features. Moreover, while manyaspects and features relate to, and are described in, the context ofankle braces, aspects and features of the invention are not limited touse only in such context, as will become apparent from the followingsummaries and detailed descriptions of aspects, features, and one ormore embodiments of the invention.

Accordingly, in a first aspect, a rear-entry ankle brace comprises anelastomeric component defining an inside elbow channel configured tospan an ankle joint of a wearer, the elastomeric component having: adistal end portion comprising an arched foot portion configured toextend over and cover a top and opposite sides of a mid-foot of thewearer; a proximal end portion comprising an arched leg portionconfigured to extend over and cover a front and sides of a lower portionof a leg of the wearer; an intermediate portion extending between thefoot portion and leg portion and comprising an arched ankle portionconfigured to extend over and cover a front and sides of an ankle jointof the wearer. Additionally, a channel opening extends along a length ofthe elastomeric component from the distal end portion to the proximalend portion and enables the elastomeric component to be positioneddirectly onto and cover the front and sides of the mid-foot, lower legportion, and ankle joint of the wearer without passing the mid-footthrough the proximal end portion. The brace further comprises one ormore straps for adjustably tensioning first and second rear edges of thechannel opening in an area of the leg portion toward one another andsecuring the leg portion to the lower leg of the wearer; and one or morestraps for adjustably tensioning first and second bottom edges of thechannel opening in an area of the foot portion toward one another andsecuring the foot portion to the mid-foot of the wearer.

In another aspect, a rear-entry ankle brace comprises an elastomericcomponent defining an inside elbow channel configured to span an anklejoint of a wearer, the elastomeric component having: a distal endportion comprising an arched foot portion configured to extend over andcover a top and opposite sides of a mid-foot of the wearer; a proximalend portion comprising an arched leg portion configured to extend overand cover a front and sides of a lower portion of a leg of the wearer;and an intermediate portion extending between the foot portion and legportion and comprising an arched ankle portion configured to extend overand cover a front and sides of an ankle joint of the wearer. A channelopening extends along a length of the elastomeric component from thedistal end portion to the proximal end portion and enables theelastomeric component to be positioned directly onto and cover the frontand sides of the mid-foot, lower leg portion, and ankle joint of thewearer without passing the mid-foot through the proximal end portion.The brace further comprises a first leg strap secured to a first rearedge of the channel opening in an area of the leg portion and a secondleg strap connected to a second rear edge of the channel opening in thearea of the leg portion, the first and second leg straps configured toremovably attach to each other for tensioning the first and second rearedges toward one another and securing the leg portion to the lower legof the wearer; and a first foot strap extending from a first bottom edgeof the channel opening an the area of the foot portion and a second footstrap extending from a second bottom edge of the channel opening in thearea of the foot portion, each of the first and second leg strapsconfigured to span the channel opening in the area of the foot portion,and to removably attach to at least one of the first and second legstraps when removably attached to each other for tensioning the firstand second bottom edges toward one another and securing the foot portionto the mid-foot of the wearer.

The first and second leg straps preferably span the channel openingbetween the first and second rear edges and overlap one another, and thebrace preferably further comprises a slot along one of the first andsecond rear edges of the channel opening in the area of the leg portionthrough which one of the first and second leg straps extends. The slotpreferably is defined by a D-ring that is at least partially embeddedwithin the elastomeric component.

In a feature, the first and second foot straps extend diagonally upwardfrom the first and second bottom edges of the channel opening and crossover each other along the intermediate portion of the elastomericcomponent when the first and second foot straps are removably attachedto at least one of the first and second leg straps for tensioning thefirst and second bottom edges toward one another and securing the footportion to the mid-foot of the wearer.

In a feature, one of the first and second foot straps is a lower footstrap that extends under the other of the first and second foot strapsthat is an upper foot strap, the lower foot strap forming a plantarsurface of the brace when spanning the channel opening in the area ofthe foot portion. The upper foot strap preferably extends through a slotalong one of the first and second bottom edges of the channel opening inthe area of the foot portion, and the slot preferably is defined by aD-ring that is at least partially embedded within the elastomericcomponent.

In another aspect, a rear-entry ankle brace comprises an elastomericcomponent defining an inside elbow channel configured to span an anklejoint of a wearer, the elastomeric component having: a distal endportion comprising an arched foot portion configured to extend over andcover a top and opposite sides of a mid-foot of the wearer; a proximalend portion comprising an arched leg portion configured to extend overand cover a front and sides of a lower portion of a leg of the wearer;and an intermediate portion extending between the foot portion and legportion and comprising an arched ankle portion configured to extend overand cover a front and sides of an ankle joint of the wearer. A channelopening extends along a length of the elastomeric component from thedistal end portion to the proximal end portion and enables theelastomeric component to be positioned directly onto and cover the frontand sides of the mid-foot, lower leg portion, and ankle joint of thewearer without passing the mid-foot through the proximal end portion.The brace further comprises a leg strap secured to a rear edge of thechannel opening in an area of the leg portion and configured to attachto a second rear edge of the channel opening in the area of the legportion removably attach to itself for tensioning the first and secondrear edges toward one another and securing the leg portion to the lowerleg of the wearer; and a first foot strap secured to and extending froma first bottom edge of the channel opening in an area of the footportion and a second foot strap secured to and extending from a secondbottom edge of the channel opening in the area of the foot portion, eachof the first and second leg straps configured to span the channelopening in the area of the foot portion, and to removably attach to theleg strap for tensioning the first and second bottom edges toward oneanother and securing the foot portion to the mid-foot of the wearer.

In a feature, the leg strap twice spans the channel opening between thefirst and second rear edges and overlaps itself, and wherein the bracefurther comprises a slot along one of the first and second rear edges ofthe channel opening in the area of the leg portion through which the legstrap extends. The slot preferably is defined by a D-ring that is atleast partially embedded within the elastomeric component.

In a feature, the first and second foot straps extend diagonally upwardfrom the first and second bottom edges of the channel opening and crossover each other along the intermediate portion of the elastomericcomponent when the first and second foot straps are removably attachedto the leg strap for tensioning the first and second bottom edges towardone another and securing the foot portion to the mid-foot of the wearer.

In a feature, one of the first and second foot straps is a lower footstrap that extends under the other of the first and second foot strapsthat is an upper foot strap, the lower foot strap forming a plantarsurface of the brace when spanning the channel opening in the area ofthe foot portion.

The upper foot strap preferably extends through a slot along one of thefirst and second bottom edges of the channel opening in the area of thefoot portion, and the slot preferably is defined by a D-ring that is atleast partially embedded within the elastomeric component.

In a feature, each said strap is removably attached to another saidstrap using hook and loop fasteners.

In another aspect, a rear-entry ankle brace comprises an elastomericcomponent defining an inside elbow channel configured to span an anklejoint of a wearer, the elastomeric component having: a distal endportion comprising an arched foot portion configured to extend over andcover a top and opposite sides of a mid-foot of the wearer; a proximalend portion comprising an arched leg portion configured to extend overand cover a front and sides of a lower portion of a leg of the wearer;and an intermediate portion extending between the foot portion and legportion and comprising an arched ankle portion configured to extend overand cover a front and sides of an ankle joint of the wearer. A channelopening extends along a length of the elastomeric component from thedistal end portion to the proximal end portion and enables theelastomeric component to be positioned directly onto and cover the frontand sides of the mid-foot, lower leg portion, and ankle joint of thewearer without passing the mid-foot through the proximal end portion.The brace further comprises means for adjustably tensioning first andsecond rear edges of the channel opening in an area of the leg portiontoward one another and securing the leg portion to the lower leg of thewearer; and means for adjustably tensioning first and second bottomedges of the channel opening in an area of the foot portion toward oneanother and securing the foot portion to the mid-foot of the wearer.

In a feature, the elastomeric component consists of a single moldedpiece of one or more thermoplastic materials.

In a feature, the elastomeric component further defines on each ofopposite lateral and medial sides of the brace a central hub withradiating struts extending from the central hub and with interstitialareas extending between the radiating struts.

The interstitial areas preferably comprises areas that are substantiallythinner than the radiating struts and that include perforationsextending through the elastomeric for breathability of the brace whenworn. Additionally, one or more of the radiating struts preferablycomprises a thickness of from 1 mm to 10 mm, a width of from 3 mm to 20mm, and a durometer of from 10 to 140 on the Shore A scale.

In a feature, elastomeric component is symmetrical relative to a planeand is adapted to be used on either a right ankle or a left ankle.

In a feature, the brace further comprises a pair of stirrups, eachattached to an inner side of the elastomeric component in opposingrelation to each other and each contoured so as to receive a respectivemalleolus of the wearer, the pair of stirrups acting as stiffening ribsin the anatomic orientation of the lateral collateral ligamentouscomplex of the ankle joint.

In another aspect, a method comprises steps for donning a rear-entryankle brace, the brace comprising an elastomeric component defining aninside elbow channel configured to span an ankle joint of a wearer, theelastomeric component having a distal end portion comprising an archedfoot portion configured to extend over and cover a top and oppositesides of a mid-foot of the wearer; a proximal end portion comprising anarched leg portion configured to extend over and cover a front and sidesof a lower portion of a leg of the wearer; and an intermediate portionextending between the foot portion and leg portion and comprising anarched ankle portion configured to extend over and cover a front andsides of an ankle joint of the wearer. A channel opening extends along alength of the elastomeric component from the distal end portion to theproximal end portion and enables the elastomeric component to bepositioned directly onto and cover the front and sides of the mid-foot,lower leg portion, and ankle joint of the wearer without passing themid-foot through the proximal end portion. The brace further comprisesone or more leg straps for tensioning first and second rear edges of thechannel opening in an area of the leg portion toward one another andsecuring the leg portion to the lower leg of the wearer; and two footstraps for tensioning first and second bottom edges of the channelopening in an area of the foot portion toward one another and securingthe foot portion to the mid-foot of the wearer. In this context, thesteps of the method comprise: positioning the elastomeric componentdirectly onto and in covering relation with the front and sides of themid-foot, lower leg portion, and ankle joint of the wearer withoutpassing the elastomeric component over the toes of the foot; tensioningthe first and second bottom edges of the channel opening in the area ofthe foot portion toward one another by pulling the two foot straps andthen stepping on the overlapping portions of the foot straps to hold thetension; bending a knee of the leg of the wearer over at least themid-foot of the wearer to tension the elastomeric component and preloadthe brace; pulling and securing the one or more leg straps to tensionthe first and second rear edges of the channel opening toward oneanother and secure the leg portion to the lower leg of the wearer; andceasing the stepping on the overlapping portions of the foot straps andseparately pulling and securing each of the foot straps to one of theone or more leg straps to selectively tension the first and secondbottom edges of the channel opening toward one another and secure thefoot portion to the mid-foot of the wearer.

In a feature, the step of positioning the elastomeric component directlyonto and in covering relation with the front and sides of the mid-foot,lower leg portion, and ankle joint of the wearer comprises positioningthe elastomeric component such that each of the central hubs aligns witha respective malleolus.

In a feature, the rear-entry ankle brace further comprises a pair ofstirrups, each attached to an inner side of the elastomeric component inopposing relation to each other and each contoured so as to receive arespective malleolus of the wearer. The step of positioning theelastomeric component directly onto and in covering relation with thefront and sides of the mid-foot, lower leg portion, and ankle joint ofthe wearer preferably comprises positioning the elastomeric componentsuch that each of the stirrups receives a respective malleolus of thewearer. Additionally, the method preferably further comprises apreliminary step of removably attaching each of the pair of stirrups tothe elastomeric component before said positioning of the elastomericcomponent.

In a feature, the method further comprises donning a shoe while thebrace is being worn, with the leg portion extending above the shoe andthe foot portion being received within the shoe.

In another aspect, an ankle brace to be worn under the shoe of a wearercomprises an elastomeric component being open to the bottom and forminga first arched foot portion along a medial foot axis with opposingbottom edges so as to accommodate the top of a mid-foot of the wearer,and forming a second arched leg portion along a medial leg axis withopposing rear edges so as to accommodate the front of the lower leg ofthe wearer. The medial axis of the foot portion forms an angle to themedial axis of the leg portion. The elastomeric component comprise apair of opposing support systems each formed by an interlinking networkof band members having a central hub and radiating struts, withinterstitial spaces extending between the band members including a flatweb of breathable material. The elastomeric component preferably has aconfiguration with mirror symmetry about a medial plane formed at theintersection of the medial axis of the foot portion and the medial axisof the leg portion. At least one foot strap extends from a first bottomedge of the foot portion and a second foot strap extends from a secondbottom edge of the foot portion and cooperates with the first foot strapto close the foot portion and form a plantar surface of the ankle; andat least one leg strap closes the leg portion about the lower leg of thewearer.

In a feature, the brace is dynamic so as store and rebalance energy byallowing pivoting motion between the foot portion and the leg portionbut inhibiting lateral and medial translational or pivotal motion aboutan axis perpendicular to the transverse axis along the length of thefoot between the foot portion and the leg portion

In a feature, the elastomeric component is formed by molding or casting.

In a feature, the brace further comprises a pair of foot straps with afirst foot strap extending from a first bottom edge of the foot portionand a second foot strap extending from a second bottom edge of the footportion which cooperating to form the plantar surface of the anklebrace. Preferably, one foot strap crosses under the other foot strap;and preferably one foot strap is connected to the bottom of theelastomeric component with an opening that receives the other foot strapto allow for the cooperation of the foot straps. One foot strap may beconnected to the bottom of the elastomeric component with a D-ring andthe opening may be a slot along the length of the D-ring.

Additional aspects and features are disclosed in the computer programlisting and in the incorporated references.

In addition to the aforementioned aspects and features of the invention,it should be noted that the invention further encompasses the variouslogical combinations and subcombinations of such aspects and features.Thus, for example, claims in this or a divisional or continuing patentapplication or applications may be separately directed to any aspect,feature, or embodiment disclosed herein, or combination thereof, withoutrequiring any other aspect, feature, or embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS

One or more preferred embodiments of the invention now will be describedin detail with reference to the accompanying drawings.

FIG. 1 is a front elevational view of a preferred rear-entry ankle bracein accordance with one or more aspects and features of the presentinvention.

FIG. 2 is a rear elevational view of the rear-entry ankle brace of FIG.1.

FIG. 3 is a first side elevational view of the rear-entry ankle brace ofFIG. 1.

FIG. 4 is a top plan view of the rear-entry ankle brace of FIG. 1.

FIG. 5 is a bottom plan view of the rear-entry ankle brace of FIG. 1.

FIG. 6 is a second, opposite side elevational view of the rear-entryankle brace of FIG. 1.

FIG. 7 is a first perspective of another preferred rear-entry anklebrace in accordance with one or more aspects and features of the presentinvention.

FIG. 8 is a first side elevational view of the rear-entry ankle brace ofFIG. 7.

FIG. 9 is a second perspective of the rear-entry ankle brace of FIG. 7.

FIG. 10 is a third perspective of the rear-entry ankle brace of FIG. 7.

FIG. 11 is a second side elevational view of the rear-entry ankle braceof FIG. 7.

FIG. 12 is a fourth perspective of the rear-entry ankle brace of FIG. 7.

FIG. 13 is a front elevational view of the rear-entry ankle brace ofFIG. 7.

FIG. 14 is a top plan of the rear-entry ankle brace of FIG. 7.

FIG. 15 is a back elevational view of the rear-entry ankle brace of FIG.7.

FIG. 16 is a perspective view of a front of a preferred stirrup of arear-entry ankle brace in accordance with one or more aspects andfeatures of the present invention.

FIG. 17 is a front elevational view of the stirrup of FIG. 16.

FIG. 18 is another perspective view of the front of the stirrup of FIG.16.

FIG. 19 is a first side elevational view of the stirrup of FIG. 16.

FIG. 20 is a top plan view of the stirrup of FIG. 16.

FIG. 21 is a second side elevational view of the stirrup of FIG. 16.

FIG. 22 is a perspective view of a front of another preferred rear-entryankle brace in accordance with one or more aspects and features of thepresent invention.

FIG. 23 is a perspective view of a rear of the rear-entry ankle brace ofFIG. 22.

FIG. 24 is a side elevational view of the rear-entry ankle brace of FIG.22 in which the straps are omitted.

FIG. 25 is a perspective view of a rear of the rear-entry ankle brace ofFIG. 24.

FIG. 26 is perspective view of a front of a rear-entry ankle brace ofFIG. 22 being worn in support of the ankle of a right leg of a wearer.

FIG. 27 is a perspective view of the medial side of the rear-entry anklebrace of FIG. 26.

FIG. 28 is a perspective view of the lateral side of the rear-entryankle brace of FIG. 26.

FIG. 29 is a perspective view of the rear-entry ankle brace of FIG. 22being worn under a shoe.

FIG. 30 is a perspective view of the medial side of the rear-entry anklebrace of FIG. 29 being worn under a shoe.

FIG. 31 is a perspective view of the rear of the rear-entry ankle braceof FIG. 29 being worn under a shoe.

FIG. 32 is a perspective view of an alternative preferred rear-entryankle brace in accordance with one or more aspects and features of thepresent invention, wherein the brace does not include the optionalstirrups.

FIG. 33 is a side elevational view of another preferred rear-entry anklebrace in accordance with one or more aspects and features of the presentinvention, wherein the elastomeric component is rendered transparent forbetter illustration of a stirrup that is attached to an inner side ofthe elastomeric component.

FIG. 34 is a perspective view of another preferred rear-entry anklebrace in accordance with one or more aspects and features of the presentinvention, wherein the brace includes a single leg strap and two footstraps instead of two leg straps and two foot straps.

FIGS. 35 through 38 each illustrates a tag that preferably is sewn ontoa strap for purposes of indicating to a wearer the sequence for securingthe brace, all in accordance with one or more aspects and features ofthe present invention.

DETAILED DESCRIPTION

As a preliminary matter, it will readily be understood by one havingordinary skill in the relevant art (“Ordinary Artisan”) that theinvention has broad utility and application. Furthermore, any embodimentdiscussed and identified as being “preferred” is considered to be partof a best mode contemplated for carrying out the invention. Otherembodiments also may be discussed for additional illustrative purposesin providing a full and enabling disclosure of the invention.Furthermore, an embodiment of the invention may incorporate only one ora plurality of the aspects of the invention disclosed herein; only oneor a plurality of the features disclosed herein; or combination thereof.As such, many embodiments are implicitly disclosed herein and fallwithin the scope of what is regarded as the invention.

Accordingly, while the invention is described herein in detail inrelation to one or more embodiments, it is to be understood that thisdisclosure is illustrative and exemplary of the invention and is mademerely for the purposes of providing a full and enabling disclosure ofthe invention. The detailed disclosure herein of one or more embodimentsis not intended, nor is to be construed, to limit the scope of patentprotection afforded the invention in any claim of a patent issuing herefrom, which scope is to be defined by the claims and the equivalentsthereof. It is not intended that the scope of patent protection affordedthe invention be defined by reading into any claim a limitation foundherein that does not explicitly appear in the claim itself.

Thus, for example, any sequence(s) and/or temporal order of steps ofvarious processes or methods that are described herein are illustrativeand not restrictive. Accordingly, it should be understood that, althoughsteps of various processes or methods may be shown and described asbeing in a sequence or temporal order, the steps of any such processesor methods are not limited to being carried out in any particularsequence or order, absent an indication otherwise. Indeed, the steps insuch processes or methods generally may be carried out in variousdifferent sequences and orders while still falling within the scope ofthe invention. Accordingly, it is intended that the scope of patentprotection afforded the invention be defined by the issued claim(s)rather than the description set forth herein.

Additionally, it is important to note that each term used herein refersto that which the Ordinary Artisan would understand such term to meanbased on the contextual use of such term herein. To the extent that themeaning of a term used herein—as understood by the Ordinary Artisanbased on the contextual use of such term—differs in any way from anyparticular dictionary definition of such term, it is intended that themeaning of the term as understood by the Ordinary Artisan shouldprevail.

With regard solely to construction of any claim with respect to theUnited States, no claim element is to be interpreted under 35 U.S.C.112(f) unless the explicit phrase “means for” or “step for” is actuallyused in such claim element, whereupon this statutory provision isintended to and should apply in the interpretation of such claimelement. With regard to any method claim including a condition precedentstep, such method requires the condition precedent to be met and thestep to be performed at least once but not necessarily every time duringperformance of the claimed method.

Furthermore, it is important to note that, as used herein, “comprising”is open-ended insofar as that which follows such term is not exclusive.Additionally, “a” and “an” each generally denotes “at least one” butdoes not exclude a plurality unless the contextual use dictatesotherwise. Thus, reference to “a picnic basket having an apple” is thesame as “a picnic basket comprising an apple” and “a picnic basketincluding an apple”, each of which identically describes “a picnicbasket having at least one apple” as well as “a picnic basket havingapples”; the picnic basket further may contain one or more other itemsbeside an apple. In contrast, reference to “a picnic basket having asingle apple” describes “a picnic basket having only one apple”; thepicnic basket further may contain one or more other items beside anapple. In contrast, “a picnic basket consisting of an apple” has only asingle item contained therein, i.e., one apple; the picnic basketcontains no other item.

When used herein to join a list of items, “or” denotes “at least one ofthe items” but does not exclude a plurality of items of the list. Thus,reference to “a picnic basket having cheese or crackers” describes “apicnic basket having cheese without crackers”, “a picnic basket havingcrackers without cheese”, and “a picnic basket having both cheese andcrackers”; the picnic basket further may contain one or more other itemsbeside cheese and crackers.

When used herein to join a list of items, “and” denotes “all of theitems of the list”. Thus, reference to “a picnic basket having cheeseand crackers” describes “a picnic basket having cheese, wherein thepicnic basket further has crackers”, as well as describes “a picnicbasket having crackers, wherein the picnic basket further has cheese”;the picnic basket further may contain one or more other items besidecheese and crackers.

The phrase “at least one” followed by a list of items joined by “and”denotes an item of the list but does not require every item of the list.Thus, “at least one of an apple and an orange” encompasses the followingmutually exclusive scenarios: there is an apple but no orange; there isan orange but no apple; and there is both an apple and an orange. Inthese scenarios if there is an apple, there may be more than one apple,and if there is an orange, there may be more than one orange. Moreover,the phrase “one or more” followed by a list of items joined by “and” isthe equivalent of “at least one” followed by the list of items joined by“and”.

Referring now to the drawings, one or more preferred embodiments of theinvention are next described. The following description of one or morepreferred embodiments is merely exemplary in nature and is in no wayintended to limit the invention, its implementations, or uses.

Specifically, a front elevational view of a preferred rear-entry anklebrace 100 in accordance with one or more aspects and features of thepresent invention is illustrated in FIG. 1. Additionally, FIG. 2 is arear elevational view of the rear-entry ankle brace 100; FIG. 3 is afirst side elevational view of the rear-entry ankle brace 100; FIG. 4 isa top plan view of the rear-entry ankle brace 100; FIG. 5 is a bottomplan view of the rear-entry ankle brace 100; and FIG. 6 is a second,opposite side elevational view of the rear-entry ankle brace 100.

With respect to another preferred rear-entry ankle brace 10 inaccordance with one or more aspects and features of the presentinvention, FIG. 7 is a first perspective view of the ankle brace 10.Additionally, FIG. 8 is a first side elevational view of the rear-entryankle brace 10; FIG. 9 is a second perspective of the rear-entry anklebrace 10; FIG. 10 is a third perspective of the rear-entry ankle brace10; FIG. 11 is a second side elevational view of the rear-entry anklebrace 10; FIG. 12 is a fourth perspective of the rear-entry ankle brace10; FIG. 13 is a front elevational view of the rear-entry ankle brace10; FIG. 14 is a top plan of the rear-entry ankle brace 10; and FIG. 15is a back elevational view of the rear-entry ankle brace 10.

The rear-entry ankle braces 100 and 10 each are shown with a pair ofoptional stirrups 150 that serve to stabilize the brace in use.Additionally, FIG. 17 is a front elevational view of a said stirrup 150;FIG. 18 is another perspective view of the front of the stirrup 150;FIG. 19 is a first side elevational view of the stirrup 150; FIG. 20 isa top plan view of the stirrup 150; and FIG. 21 is a second sideelevational view of the stirrup 150.

Each stirrup 150 is removably attached to an inside of the elastomericcomponent with the pair of stirrups being arranged in opposing facingrelation to each other. Each stirrup 150 further comprises a contouredsurface that is designed to receive a respective malleolus, and eachstirrup 150 preferably comprises a molded, rigid component 151 thatprovides stiffness to the elastomeric component and a foam component 153for comfort of the wearer.

Yet another preferred rear-entry ankle brace 300 in accordance with oneor more aspects and features of the present invention is illustrated inFIGS. 22-25. Specifically, FIG. 22 is a first perspective view of afront of another preferred rear-entry ankle brace 300; FIG. 23 is aperspective view of a rear of the rear-entry ankle brace 300; FIG. 24 isa side elevational view of the rear-entry ankle brace 300 in which thestraps are omitted; and FIG. 25 is a perspective view of a rear of therear-entry ankle brace 300.

Braces of preferred embodiments of the invention are intended to be workunder shoes. In this respect, FIGS. 26-28 show the brace 300 after beingdonned by a wearer, and FIGS. 29-31 show the subsequent use of the brace300 by the wearer after donning a shoe. Specifically, FIG. 26 isperspective view of a front of the rear-entry ankle brace 300 being wornin support of the ankle of a right leg of the wearer; FIG. 27 is aperspective view of the medial side of the rear-entry ankle brace 300;and FIG. 28 is a perspective view of the lateral side of the rear-entryankle brace 300. FIG. 29 is a perspective view of the rear-entry anklebrace 300 being worn under a shoe; FIG. 30 is a perspective view of themedial side of the rear-entry ankle brace 300 being worn under a shoe;and FIG. 31 is a perspective view of the rear of the rear-entry anklebrace 300 being worn under a shoe.

FIG. 32 is a perspective view of an alternative preferred rear-entryankle brace 400 in accordance with one or more aspects and features ofthe present invention, wherein the brace 400 is shown without optionalstirrups 150.

FIG. 33 is a side elevational view of another preferred rear-entry anklebrace 500 in accordance with one or more aspects and features of thepresent invention, wherein the elastomeric component is renderedtransparent for better illustration of a stirrup 150 that is attached toan inner side of the elastomeric component.

FIG. 34 is a perspective view of another preferred rear-entry anklebrace 600 in accordance with one or more aspects and features of thepresent invention, wherein the brace 600 includes a single leg strap 602and two foot straps 604,606.

FIG. 35 through FIG. 38 each illustrates a tag that preferably is sewnonto a strap for purposes of indicating to a wearer the sequence forsecuring the brace, all in accordance with one or more aspects andfeatures of the present invention. Specifically, FIG. 35 illustrates afirst tag 702 showing the wrapping of a first leg strap around the legportion of the brace and FIG. 36 illustrates a second tag 704 showingthe wrapping of a second leg strap around the leg portion in theopposite direction and the attachment of the second leg strap to thefirst leg strap using, preferably, hook-and-loop fasteners. FIG. 37illustrates a third tag 706 showing the subsequent wrapping of a firstfoot strap from a bottom edge of the foot portion diagonally upward andattachment of the end of the first foot strap to the first leg strap,preferably using hook-and-loop fasteners. Lastly, FIG. 38 illustrates afourth tag 708 showing the subsequent wrapping of a second foot strapfrom an opposite bottom edge of the foot portion diagonally upward,across the first foot strap, and attachment of the end of the secondfoot strap to the first and/or second leg straps, preferably usinghook-and-loop fasteners. The first tag 702 preferably is sewn orotherwise attached to an inside surface of the first leg strap; thesecond tag 704 preferably is sewn or otherwise attached to an insidesurface of the second leg strap; the third tag 706 preferably is sewn orotherwise attached to an inside surface of the first foot strap; and thefourth tag 708 preferably is sewn or otherwise attached to an insidesurface of the second foot strap. None of the tags preferably arevisible when the brace is fully secured with the straps. For braces witha single leg strap, tag 704 preferably is omitted with tag 702alternatively showing how to wrap the single leg strap back over itselfand around the leg portion.

Returning now to FIGS. 7-21, preferred embodiments will be described ingreater detail for a fuller understanding of aspects and features of theinvention. With specific reference to rear-entry brace 10, thispreferred brace 10 comprises an assembly of components including anelastomeric component 20, two leg straps 50, and two foot straps 80. Theleg straps 50 are configured to encircle and secure the brace 10 to theleg, and the two foot straps 80 are configured to encircle and secureand secure the brace 10 to the foot.

The elastomeric component 20 itself comprises lateral and medial supportsystems 22 each made of an interlinking set of bands 23 which includesupports or strut members 23 which radiate outwardly from a centralringed hub 25 that surrounds a respective malleolus on a side of theankle. The lateral and medial support systems 22 are part of a joinedtransverse double arch, like an open elbow conduit or inside elbowchannel, with one arch 26 for the lower leg and the transverse arch 28for the mid-foot area. The support systems 22 include interstitial areas30 that are more flexible. These areas or “fenestrations” can be openareas, or more preferably include an interconnecting or spanning web ofsofter material. The support systems 22 are joined in the front of theleg, and top of the foot in a front fold 32 formed by a fenestration inthe general shape of a diamond. The combination of the double hubs 25and support systems 22 and the front fold 32 form a self-hinge to permitthe brace and ankle to hinge at an axis formed between the malleolirings or hubs 25. Additionally, the hubs include a break or area oflower volume of material to encourage hinging about an ankle transverseto the medial plane of the brace and through the opposing hub members.The medial and lateral hub and strut systems 22 thereby are believed toinhibit torsion or twisting of the ankle (i.e., inversion or eversion).

The configuration of the elastomeric component 20 itself preferably hasa mirror symmetry about the medial plane whereby the elastomericcomponent can be used for either a left or right ankle. The symmetrydoes not need to extend to the straps where it is possible that only oneside of the brace includes a leg or foot closure strap, for example,which can double back on itself, or includes a D-ring attachment with aslotted opening to allow a mating strap to be feed through the slot.

So as to be a “rear-entry” brace 10, the elastomeric component 20 isopen to the rear of the ankle and bottom of the foot (includes alongitudinal channel opening) whereby the brace 10 can be directlyplaced directly onto the foot from the front of the foot and closed atthe top and around the mid-foot by two sets of closure means, such asadjustable straps, i.e., one leg strap or a set of two leg straps 50 atthe top of the leg portion 26, and two foot straps 80 at the bottom ofthe foot portion 28.

Advantageously, the foot closure means 51 of the ankle brace 10 includesa pair of foot straps 80 that are connected to or extend from the bottomedge of the foot portion 28 of the elastomeric component. These straps50 wrap under the foot and form a self-sole 52 and a plantar surface ofthe brace 10. The straps 50 can include provisions for additionalsupport, or cushioning under the foot, or for additional rigidity,stiffness, or padding, as desired. Ideally, one strap 50 is attached tothe elastomeric component 20 to allow the other strap 50 to feed throughthe elastomeric component, the strap, or the connection between thestrap and the elastomeric component so that the foot straps 50 overlapto close the elastomeric component about the wearer's foot.

The foot straps 80 may comprise an elastomer or a stretch fabric, and inparticular, the straps may have elastic portions that cross and wrapover the front of the ankle which add additional elastic variableresistance that is distributed through the elastomeric component to theankle during use. This tensioned resistance can be tailored toindividual use by slight changes in the direction and amount of pull inputting the brace on and by changing the angle or the location at whichthe strap ends are fastened on the leg straps that have mating fasteningmeans.

The foot portion 28 has a distal opening 16 that may include a bandmember and that is configured to snugly surround the user's foot, atapproximately the neck of the fifth metatarsal through the plantarsurface to the middle of the first metatarsal and arching proximallytoward the tibial fibular talar joint over the dorsal surface of thefoot. At the other end, the foot portion 28 ends on the plantar sideposterior to the end of the medial arch in a heel opening 18 which isbehind the fat pad of the heel (approximately ½ of the way posteriortoward the heel end of the calcaneus) on the posterior side, and belowthe insertion of the gastrocnemius into the Achilles tendon as itextends upward on the leg to form the bottom boundary of the leg portionof the brace. The foot portion 28 ends on the anterior side of the ankleat the “eye of the ankle”, i.e., on the superficial aspect of theanterior ankle at the joint of the tibia/fibula/talus (or the “TFT”joint). The foot portion 28 includes a blanket or web of material(preferably molded or cast) that covers an area corresponding to thecuneiforms and the cuboid bone and the navicular bone. On the medial andlateral sides of the brace, the foot portion runs diagonally between theanterior and posterior openings where it joins the leg portion 26 whichsurrounds the bottom portion of the leg or the vertical portion of theankle approximately ⅓ of the way up the lower leg, and below the belliesof the distal aspect of the gastrocnemius.

The leg portion 26 of the brace includes a pair of leg straps 80 thatextend from the rear edges 38 of the leg portion 26 of the elastomericcomponent. Preferably, the closure means 81 of the leg portion includestwo straps where one is connected to the leg portion of the elastomericcomponent such that the second leg strap can be threaded through arecess in the first strap, or in the elastomeric component, or in theconnection between the strap and the elastomeric component, such as bythe provision of a D-ring for re-enforcement of the connection to theelastomeric component 20 and to provide a slot which receives theopposing strap 80. The leg straps 80 wrap around the leg portion of thebrace which may advantageously include a lip to help to hold the strapin position on the brace The leg straps further include fastening means,such as a segment of a hook and loop landing pad that serves to receivethe fastener opposing segment on the other leg strap 80, and furtherwhich anchors the ends of the foot straps 50 which extend upward fromthe bottom of the foot portion 28 of the elastomeric component 20 andform an foot strap portion that is thinner in width where they crossdiagonally over each other in a figure of eight design (best representedin FIG. 1) and have a closure means such as a terminal tab with hook orloop on the interior side and which fastens on the landing pad of theleg strap 80. This provides a figure of eight over the front of theankle joint to stabilize the syndesmosis. This portion of the footstraps can have an elasticity that is engineered for greater or lessstretch to provide the desired flex and support at this vulnerable partof the ankle.

Thus, the invention generally provides an athletic and/or therapeuticorthopedic brace or support 10 which comprises an elastomeric component20 having integrally formed interlinking bands that resist and directactive forces joined together for greater stability by thinner and moreflexible or elastic webs of material in the interstitial spaces, whichare referred to herein as “fenestrations”. The term “fenestrations” areused herein to refer to areas of reduced support, which may be openingsor which may include a webbed area of a softer or more yielding materialcharacterized by a lower durometer material, preferably havingperforations to allow the webbed area or webs of material to allowperspiration to pass through. Advantageously, the web of material isformed as thinner areas of the same material as the support bands, sothat the elastomeric component can be formed as an integral unit, suchas by molding the elastomer.

Preferably the elastomeric component 20 includes two sets ofinterconnected opposing support systems 22 which have a central ring orhub 25 joined to radiating strut or support members 23. Theinterconnected opposing support systems are designed to encourage thebrace to allow pivoting motion at the ankle joint, but to inhibittwisting or movement off-axis. This allows the ankle to continue tofunction as a hinge for athletics while helping to protect a vulnerableankle. Thus, the brace surrounds and supports the ankle so as to providean external anatomically configured framework that mimics or augmentsthe effects of the ligaments, and further acts to rebound or re-directdynamic forces that the ankle generates or encounters. In theenvironment of the brace, the invention includes a self-formed hingesystem that is engineered to allow motion in a controlled manner, sothat the supported joint may be flexed in a direction that is notharmful but where potentially harmful motion is inhibited by the brace.

The integral elastomeric component member 20 includes a pair of centralsupport structures 22 (i.e., the lateral and medial malleoli supportmembers or rings) that together define an axis of motion across themalleoli. The support member preferably comprises opposing hub members,such as on the medial and lateral side of the ankle, (or possibly infurther embodiments for the knee or elbow joint) which members togetherdefine an axis about which a first member of the brace hinges or pivotsrelative to a second member of the brace. Together these hub membersinclude an opening or weakened area in the middle which overlays theankle bones (i.e., malleoli) to define an axis about which the anklehinges and which the brace permits while still inhibiting movement inother planes, such as torsion or twisting. The two sets of supportmembers are joined to from two to eight strut members 23 or bands whichradiate away from the support members to form a vertical side support oneach side. Advantageously, the elastomeric component 20 demonstratesmirror symmetry from the lateral and medial side so that the elastomericcomponent 20 can be worn on either a left or right ankle (i.e., is“universal”). The medial and lateral support systems comprised of thecentral hub and radiating struts are joined together over the top of thefoot and front of the ankle in a fenestration that is preferably diamondshaped, again to permit flexing about the ankle joint during permittedmovement.

The brace further includes negative or void areas, such as weakenedareas, recesses or apertures that act to re-direct forces through thecomplementary areas which assume the stresses in response to theexistence of the negative area. The weakened areas can comprisecomplimentary webs of softer, more yielding, lower durometer material,e.g., having a durometer of 35+/−10, and preferably 45+/−5 5, on theShore A scale. This material may also include perforations, such aspores or holes of 0.0001-0.05 inch diameter, to allow for theevaporation of perspiration. These pores may also affect the softness ofthe material.

The higher stiffness (or lower elasticity or resistance to stretch) canbe effected by a number of methods, including a change in material, achange in material characteristics, including cross-linking or durometerwhich can be caused by the manufacturing method or by the ingredients,or a change in the geometry, including thicker or wider or higher volumeof material so as to direct, inhibit or manipulate forces transmitted tothe affected joint during use.

Embodiments of the invention thus relate to generally to a soft,flexible, elastomeric universal rear-entry ankle brace for use under ashoe and which is engineered to deform so as to allow and direct apreferential direction of movement through the support system. The braceis a universal brace, meaning that a single brace is designed for use oneither the left or right ankle of a wearer. It is further designed toallow for a wide range of adjustment in the circumferential shape of thefoot and ankle to minimize inventory and sizing requirements. This isachieved by providing a molded elastomeric elbow-shaped elastomericcomponent with a front leg portion and a front foot portion which has astructure with mirror symmetry about a medial plane. The elastomericcomponent has a thickened interlinking framework with central rings andradiating struts interconnected with areas of less thick perforated websof material. The back of the elastomeric component is open to allow thewearer to put the brace on and a set of top (proximal) straps encirclesthe leg at the top of the brace to close the brace about the leg.

Advantageously, the support system members comprise a network ofelastomeric supports, (preferably band members that are longer than theyare wide and wider than they are thick so as to comfortably distributethe tension that they apply to the user) and also includes a pluralityof strut members (once again elastomeric band members) comprising afirst set of struts on the medial side of the ankle brace and a secondset of struts on the lateral side of the ankle. The medial set of strutsradiate outwardly from the medial support or hub and are linked to theperiphery of the brace on the medial side and the lateral set of strutsradial outwardly from the lateral support or hub and are linked to theperiphery of the brace on the lateral side of the brace. The bottom ofthe elastomeric component is open and a set of overlapping foot strapsform a planar surface and close the foot portion of the brace. The endsof the foot straps cross each other across a front fold of the braceover the front of the ankle joint and the foot straps fasten by means ofhook and loop on the exterior leg strap. On one side a leg strap isjoined to the elastomeric component with a slot opening for the otherleg strap which allows the straps to overlap each other, and a similarstructure joins the foot straps to allow over-lapping. The slot isadvantageously formed using a D-ring reinforcement connector.

The straps can include means for fastening or adjustment, including forexample, the hook-and-loop fasteners such as those of a Velcro™fastening assembly. The mating portion of the fastening means canadvantageously be held on straps that extend from the rear of the brace,such as a medial strap and a lateral strap which encircle the ankle orwhich spiral about the ankle so as to direct the tension of the bracearound the ankle, and around the brace.

The spaced support systems act to limit the lateral motion (i.e., sideto side or torque or twisting) while allowing the hinging of the bracemuch in the way that the spokes of a wire spoked wheel or the cables ofa tension bridge act to support the elastomeric component in tensionwhile the elastomeric component accepts and transmits compressiveforces. In accordance with this invention, the support systems 22 areengineered to allow for preferential deformation of the shape of thesupport, for example, by hinging at the front fold provided by thediamond fenestration 32 at the front of the ankle, to preferentiallyallow or direct motion within or at the support member or members. Morespecifically, the support member at each the malleolus includes asection of reduced rigidity, such as a section of reduced volume(including a reduced width, thickness, or absent length i.e., adiscontinuity such as a notch or gap) so as to encourage the deformationof the support at a specific location or for example, for a ringed band,a defined buckling or lapping which allows the first and second braceparts to hinge about an axis defined by the support member or hub 25.Alternatively, the section can be a section of material having increasedelasticity, such as an area in which there is a lesser degree ofcross-linking. The malleoli supports are generally ringed supportmembers (i.e., bands) that from a complete 360° circuit (optionally insome embodiments of the hinge member minus a small section such as1-20°, and preferably 2-10°, and most preferably 3-7°), which mayadvantageously be a circle, oval, or ellipse, but which also form alinear support, such as a quadrangle, or a hexagon or geometric shape.Thus, the brace encourages motion, including rebound or re-coil in thepermitted direction while inhibiting motion that is more likely to havethe potential to harm the joint.

In the exemplary ankle brace, the set of struts 23 (i.e., elastomericbands which act in tension as struts) thus includes one or two upwardlyextending strut members that join at the bottom to the malleolus supportor hub and on the top to a proximal portion of the brace network and oneor two diagonally extending strut members that extend from the medialsupport or hub to a distal portion of the brace network (the proximaland distal portions can optionally include bands to further re-enforceand distribute tension, although the foot and leg straps can serve thisfunction so as to eliminate the need for the end bands and allow foreasier accommodation of a shoe). Each bottom edge of the elastomericcomponent is joined to a foot strap that lays against the plantarsurface of the foot and extends upward and diagonally over the front ofthe ankle to cross over the front fold. These straps can include areasof differing stretch so as to engineer the amount of give and supportthat the straps provide for the syndesmosis. The back edges 38 of theelastomeric component includes a set of leg straps 80 that wrap aroundthe top of the elastomeric component 20 to close the brace about theleg. At least one of the straps includes an exterior section of hook orloop as a landing area for fastening the foot straps and the mating legstrap. This configuration of the brace allows a rear entry brace whichcloses around the front in such a way that the closure means serveprimarily for sizing and tightening, and are not subject to the directforces that tend to cause closure means to wear out, for example, whenthe hook and loop of Velcro™ is tensioned along the direction offastening.

The hinge system of the invention can be used in braces which are usedprophylactically (for example, allowing sufficient range of motion toallow the brace to be worn during athletic activities without hinderingthe athlete, but which acts to support the joint or joint complex and toinhibit potentially harmful motion) or the brace can be usedtherapeutically (for example, in the aid of healing of a joint or jointcomplex which has suffered some previous injury). The brace hasapplication in all of the joints, including the shoulder, elbow, wrist,hand, thumb, foot, knee, hip and back and the concepts of the presentinvention can be applied to each of these joint complexes, but isillustrated specifically with respect to an ankle brace.

Thus, the brace of the current invention is designed to allow as muchsafe freedom of movement to the wearer as possible, but to provideresistance to movement that could be harmful. In particular, the deviceis intended to inhibit inversion in plantar flexion (and to helpstabilize the syndesmotic ligament) so as to avoid “rolling” an ankle.The brace is intended to provide external support tantamount to externalligaments and or fascia, which reinforces in proper places but whichrelieves pressure where it is needed. Thus, the device acts in tensionand compression to buttress the syndesmotic ligament at the top, and inthe cross-configuration to buttress the ATFL (anterior tibiofibularligament), and the CFL (calcaneal fibular ligament), with a medial webmember that buttresses the deltoid ligament. In addition, theelastomeric nature of the brace material, and in particular of the hingesystem, coupled with the form can act to provide energy re-balance tothe wearer, where the kinetic energy is re-circulated or re-coiled tothe user, while inhibiting potentially dangerous forces applied to thejoint complex. The material also provides proprioceptive feed-back tothe user and the elasticity and/or stickiness of the material helps toremind the user to maintain tone. It is preferable that the material is“alive” or slightly sticky to the skin of the wearer. A desirable levelof stickiness would be the feel of slightly under-cured natural latex,or a material that has been exposed and allowed to dry to a solution ofsugar-water, or something less adhesive than a traditional band-aid or alight masking tape. Acceptable values measured according to ASTM,D3330D/D3330M, Test Method F at 90°, for peel adhesion of pressuresensitive tape, would be 0.0005-50 N/100 mm, preferable 0.5-30 N/100 mm,and most preferably 0.2-25 N/100 mm.

In a further embodiment of the invention, a pair of additional, andoptionally internal adjustable vertical supports 150 or “stirrups” areprovided to provide joint stability against typical directions ofligament strain. Specifically, as relates to the brace of the presentinvention in use for ankle support, the stirrups are provided as one ormore additional add-on more rigid (as compared to the elastomericcomponent) elastomeric members that extend vertically up the lateraland/or medial aspect of the brace at the malleoli, and optionallyincluding an opening over the malleoli to provide one or more line ofsupport about the ankle joint. The pair of stirrups have mirror outlineswith a rounded bottom portion 152 having a central opening 154 for amalleolus and upwardly extending front 156 and back 158 portions havinga medial slot opening 160 with a horizontal connection 162 or bridgewhich joins the two front 156 and back 158 sections to stabilize them.The interior of the stirrup is formed in a generally cylindrical shapewith a more convex section leading to the central opening such that ageneralized mating shape to the lateral or medial topography of theankle is formed. The stirrups are used on both sides of the ankle togive vertical stability and initially can be used with tape, and thenmounted on the interior of the brace for a more active rehabilitation.They have easy attachment means 170 that cooperate with the brace 10,such as a button 172 which engages an opening 174 in the elastomericcomponent 20.

In addition, the elastomeric nature of the brace material, coupled withthe form can act dynamically to provide energy re-balance to the wearer,where the kinetic energy created in a muscular exertion of the user isre-circulated or re-coiled to the user, while inhibiting potentiallydangerous forces applied to the joint complex. The “spring” thatresults, and the resilient contact of the brace with the surface of theankle, also provides a proprioceptive feel to the user that helps toprotect the ankle joint. Thus, the brace can be used to train theexertion or exercise the foot and ankle of the wearer.

It is of advantage that the support means act to inhibit stress to thesyndesmotic ligament, to the TFTL, and to the TCL. Thus, the foot strapsprovide support means which advantageously extend from the plantarsupport diagonally upward across the anterior hinge of the ankle in thevicinity of the cuboid and navicular bones, and possibly even to afurther support member or anchor at the proximal end of the lower legportion of the brace. These means can include straps that are designedso as to provide for adjustable degrees of tensioning, as well asadjustable directions of tensioning to allow the wearer to customize thefeel and size. The device acts in tension and compression to buttressthe syndesmotic ligament at the top, and in the cross-configuration tobuttress the ATFL (anterior tibiofibular ligament), and the CFL(calcaneal fibular ligament), with a medial web member that buttressesthe deltoid ligament.

The present invention is designed to provide some syndesmosis stabilityabove the malleoli. In a further adjustable embodiment, it illustratedwith a rear entry, i.e., open toward the posterior portion of the leg,but with an adjustable closure fixation point more anterior oranterolateral, (preferably not medial), with tension from posteromedialto lateral so as to pull the fibula anteriorly to help with syndesmosisstability and ankle. The superior leg band is comprised of a reasonablyhigh tensile strength to protect the syndesmosis. The brace is designedto provide a definite end to plantar flexion and inversion and also somelevel of protection on the syndesmosis.

These support systems should have a definite endpoint at say 90-110% ofphysiological plantar flexion/inversion before easing to a firm stop atwhich point there is recoil. The struts are band members which are from2-10× (and preferably from 3-8×, and most preferably from 4-6×) as wideas they are thick. The elastomeric component member of the brace isintended to be very tight on the user with a low tensile strength anddurometer so that it molds well to the ankle. The struts have a hightensile strength that eases to a firm end-point before recoiling. Inaddition, tensioning or closure mechanisms permit the wearer to pullthrough them and get a feel of tension, which provides a reassuring feelto the wearer. This tension is set such that it could result in a veryhigh tensile strength at the end of range of range so that it can bereally quite stiff within a range that is totally safe for the user.Optional closure mechanisms include various mechanisms, such ashook-and-loop fasteners, e.g., Velcro™ fasteners.

Advantageously, the foot and leg straps each provides for ½ to 1centimeters of adjustability, (in particular if the brace is provided inthree sizes), depending on the material of the tensioning means and thesize range for which the brace is intended.

In addition, in a further embodiment, the brace is illustrated asincluding a framework of a stiffer, i.e., higher durometer material, ofapproximately 60 durometer+/−15, preferably +/−10 and most preferably+/−5 on the Shore A scale. Advantageously, the foot portion 28 alsoincludes at least two, but optionally more, (i.e., two three, four ormore), symmetrically placed about the medial plane, v-shaped (or othershape which include a wider opening and a tapering portion which resistsbut will allow for expansion of the circumference of the ring) gussetswhich allows the proximal opening to expand without losing its functionas an anchor in order to allow for size variations of the wearer. Thefenestrations in this case, are actually areas of integrated softermaterial, for example having a durometer of 40+/−10, and preferably +1-5on the Shore A scale. This material is a relatively soft sheet ofelastomeric material, with a uniform thickness from surface to surface,which is slightly sticky to the touch, as can be formed by injectionmolding or by casting at a lower cross-linking. This softer portion canalso include perforations to allow for perspiration, or can includetexturing to the surface for proprioceptive reasons. The web portion atthe gusset may be advantageously strengthened, for example byeliminating the perforations in the remainder of the web in order toprovide for greater strength here since the front of the network is openfrom the network to provide for greater fit.

The brace 10 is made, for example by molding such as injection ortransfer molding, liquid silicone molding or reaction in mold casting, abio-compatible elastomer from a material of suitable durometer toprovide the desired fit, and elastomeric characteristics. The bracepreferably is made of a material that exhibits equal stretch in at leasttwo dimensions (i.e., the X, Y directions). This material can be mademore resistant to provide further support, for example of thesyndesmotic ligament, by various means, including the additional ofsupports or struts which might be provided by an integral (samematerial) thickening of the brace in a defined area, or by changes inthe material itself, such as higher rate of cure or cross-linking or theaddition of other materials such as reinforcing fibers or the use of asecond elastomeric material having greater resistance to an appliedforce, like a higher durometer or Young's modulus or modulus ofelasticity, and which could be embedded in the brace, co-molded, oradhered to the inside or outside of the brace. The brace is designed toallow motion with a limited end-point; to encourage the recoil of energyand to allow for the potential prevention of harmful forces, i.e., thebrace permits motion that is safe within a defined range, but inhibitsabnormal or dangerous motion.

The brace 10 is intended to be very tight on the user with a low tensilestrength and durometer so that it molds well to the ankle. The materialof the brace is ideally an elastomer, including for example, athermoplastic elastomer having a Shore A hardness of 2-75 at 10 sec whenmeasured in accordance with ASTM D2240, and a tensile break at stretchof 2-6 MPa at 23° C. using Die C2 hour when measured in accordance withASTM D412, tensile stress of 0.08 to 0.8 MPa at strain 100% and 0.2 to1.5 MPa at 300% at 23° C. using Die C2 hour when measured in accordancewith ASTM D412, and an Elongation at break of 800-1200% at 23° C. usingDie C2 hour when measured in accordance with ASTM D414, a tear strengthof 7.5-20 kN/m when measured in accordance with ASTM D624, and acompression set of 5-30% at 23° C. and at Time 79200 sec when measuredin accordance with ASTM D395. Thermoplastic elastomers are suitablematerials, alone, or compounded with additional materials, such as othercross-linking agents, additional elastomers to achieve materialcharacteristics, reinforcing fibers and fillers, antimicrobial agents,colorants, and fragrances. The brace 10 could further include a fabricbacking over an entire surface or over portions of a surface in order tocontrol the directions of resistance including a weave such as a biasweave fabric, which limits the stretch to one axis and inhibits thestretch along the other two axes.

The through thickness of the elastomeric component will depend on thematerial and elasticity but is preferably “low profile” meaning that itcan be worn, optionally with socks, under a user's shoe, meaning that itdoes not require a different size than is worn without the brace.Preferably the thickness would be form 2-to-10 mm, and more narrowly 5-8mm.

It further will be appreciated from the foregoing that embodiments ofthe invention provide a dynamic brace assembly having an elastomericcomponent with a pair of associated foot straps and at least one legstrap, and preferably a pair of leg straps, which fastens theelastomeric component about the leg and foot. The brace assembly is“universal” insofar as the brace assembly can be worn in support of theleft ankle or the right ankle. Furthermore, the elastomeric componentcomprises an opposing set of lateral and medial support systems made ofan interlinking set of bands or strut members which radiate outward froma central ringed hub that surrounds the malleoli. This design is“dynamic” insofar as it allows for the directional transfer of dynamicforces through the band system and as further stabilized and mediatedthrough the intermediate spaces of thinner, perforated webbing, whichalso allows for air and perspiration to pass through the brace. Inaddition, the band system and intermediate webbing may be integrated orformed from one homogenous material, such as by molding or casting withthe bands being thicker so as to be less elastic than the webbing.

The opposing set of lateral and medial support systems are part of aunitary joined transverse double arch, like an open elbow conduit or“inside elbow channel”, with one arch for the lower leg and thetransverse arch for the mid-foot area. Here, transverse is used loosely,where the angle between the medial axes of the lower leg and the footarches may be 900+/−25°, and preferably +/−15°, or 10°. The supportsystems are joined in the front of the leg, and top of the foot in afront fold formed by a fenestration in the shape of a diamond with theside angles corresponding to the hubs at the malleoli. The combinationof the double hub and strut support systems and the front fold form aself-hinge to permit the brace and ankle to hinge at an axis formedbetween the malleoli rings or hubs. The malleoli rings have aninterrupted or thinned area to encourage the hinging action of the braceand permit comfortable wear during active use.

The medial and lateral hub and strut systems inhibit torsion or twistingof the ankle (i.e., inversion or eversion). The functional configuration(i.e., the outline, through shape and topography) of the elastomericcomponent has mirror symmetry about the medial plane of the elastomericcomponent in order that the elastomeric component can be used for eithera left or right ankle. The symmetry does not need to extend to theconnection for the straps, as it is possible for example that only oneside includes a D-ring attachment with a slotted opening to allow amating strap to be feed through the slot.

The elastomeric component is open to the rear of the ankle and bottom ofthe foot to allow the brace assembly to be rear entry, meaning that itcan be placed or slid onto the foot from the top or front of the footand closed by two sets of adjustable straps, one strap or set of strapsat the top of the leg portion, and one set of at least two straps at thebottom of the foot portion.

The ankle brace includes a pair of foot straps that are connected to orextend from the bottom edge of the foot portion of the elastomericcomponent. These straps wrap under the foot and form a self-soul for theplantar surface. In further embodiments, the brace can include a soul,or be directly incorporated into a shoe. The straps can includeprovisions for additional support, or cushioning under the foot, or foradditional rigidity, stiffness, or padding. Ideally, one strap isattached to the elastomeric component to allow the other strap to feedthrough the elastomeric component, the strap, or the connection betweenthe strap and the elastomeric component so that the foot straps overlapto close the elastomeric component about the foot. The straps mayinclude areas of varying stretch, such as an area where one is joined tothe elastomeric component which does not stretch and an adjacent areathat does stretch, or a terminal area with hook and loop fastening meansthat does not stretch.

Likewise, the leg portion of the brace includes at least one leg strapthat extends from the rear edge of the leg portion of the elastomericcomponent. Preferably, the leg portion includes two straps, again, whereone is connected to the leg portion of the elastomeric component suchthat the second leg strap can be threaded through the strap, theelastomeric component, or the connection between the strap and theelastomeric component, such as by the provision of a d-ring forre-enforcement of the connection and to provide a slot which receivesthe opposing strap. The leg straps wrap around the ankle to seat below alip at the top of the leg portion of the brace. One or both of the legstraps includes a segment of a hook and loop landing pad that serves toreceive the opposing segment on the other leg strap, and further whichanchors the ends of the foot straps which extend upward from the bottomof the foot portion of the elastomeric component and thin in width wherethey cross diagonally over each other and fasten to the leg strap. Thisprovides a “figure of eight” over the front of the ankle joint tostabilize the syndesmosis.

Embodiments of the invention further relate to a pair of verticalstabilizers or stirrup members that can be used in conjunction with thebrace or independently thereof. The stirrup members have complextopographies which are roughly portions of cylinders to fit around anankle from 1 to 3 inches below the malleolus to 3 to 6 above themalleolus on each side with co-extensive inner and outer surfaces morespecifically shaped to cradle the lateral and medial sides of the anklejoint and provide vertical support. The stirrups are generalized to auniversal pair for left and right usage without specific right and leftlateral and medial members with a roughly rectangular outline ofsufficient height to extend above an ankle bone by several inches (i.e.,5.5+/−2 inches). The stirrups each have a central opening that has alonger upright portion which extends into a rounded or diagonal ovalbottom to surround and support the malleolus. The central slot openingextends from the top edge of the stirrup to a round opening near thebottom for a malleolus. Partway near the top (i.e., about 1-3 inchesdown or from ⅕ to ⅓ of the height of the opening), the slot includes asmall linking member or bridge that connects the front and back portionsof the stirrup. The stirrup further includes at least one, andpreferably two or more button fasteners that can feed through acorresponding opening in the brace member. These are advantageouslylocated near the linking member but behind or in front of the slot, andcentrally below the malleolus opening in the central slot opening.

Preferred ankle braces of the invention are soft and flexible. It isthin and comfortable for daily wear under a shoe, as part of a dailyroutine and during athletics. It permits safe movement and guardsagainst twisting or torsion that could harm vulnerable soft tissue. Theelastomeric properties of the material from which it is made, along withthe form provided by bands of thicker areas of material and interstitialfenestrations of thinner areas of material, cause the brace to bedynamic, i.e., to direct energetic forces through the brace during useto rebound the forces that the user applies and encounters during wear,including to create proprioception and to exercise the many fineco-ordinations of the foot and ankle system. The design is a universaldesign which greatly simplifies the complexities of manufacturing andinventory since the brace can be worn on the left or right ankle andprovides for adjustment such that a wide range of individual ankle sizeand confirmation can be accommodated by a very few set of sizes, such asa small, medium, and large size brace. A pair of semi-rigid stirrups areprovided for use under the brace for more therapeutic applications andin the early phases for rehabilitation from injury. A set providesopposing stirrups which can be interchanged as the medial and lateralstirrups so a single set work for both the left and right ankle and alsoto accommodate a variety of ankle shapes and sizes. Each stirrup isdesigned to provide vertical stability with a circumferentialflexibility.

Based on the foregoing description, it will be readily understood bythose persons skilled in the art that the invention has broad utilityand application. Many embodiments and adaptations of the invention otherthan those specifically described herein, as well as many variations,modifications, and equivalent arrangements, will be apparent from orreasonably suggested by the invention and the foregoing descriptionsthereof, without departing from the substance or scope of the invention.Accordingly, while the invention has been described herein in detail inrelation to one or more preferred embodiments, it is to be understoodthat this disclosure is only illustrative and exemplary of the inventionand is made merely for the purpose of providing a full and enablingdisclosure of the invention. The foregoing disclosure is not intended tobe construed to limit the invention or otherwise exclude any such otherembodiments, adaptations, variations, modifications or equivalentarrangements, the invention being limited only by the claims appendedhereto and the equivalents thereof.

1. A rear-entry ankle brace, comprising: (a) an elastomeric componentdefining an inside elbow channel configured to span an ankle joint of awearer, the elastomeric component having (i) a distal end portioncomprising an arched foot portion configured to extend over and cover atop and opposite sides of a mid-foot of the wearer, (ii) a proximal endportion comprising an arched leg portion configured to extend over andcover a front and sides of a lower portion of a leg of the wearer, and(iii) an intermediate portion extending between the foot portion and legportion and comprising an arched ankle portion configured to extend overand cover a front and sides of an ankle joint of the wearer, (iv)wherein a channel opening extends along a length of the elastomericcomponent from the distal end portion to the proximal end portion andenables the elastomeric component to be positioned directly onto andcover the front and sides of the mid-foot, lower leg portion, and anklejoint of the wearer without passing the mid-foot through the proximalend portion; (b) one or more straps for adjustably tensioning first andsecond rear edges of the channel opening in an area of the leg portiontoward one another and securing the leg portion to the lower leg of thewearer; and (c) one or more straps for adjustably tensioning first andsecond bottom edges of the channel opening in an area of the footportion toward one another and securing the foot portion to the mid-footof the wearer.
 2. A rear-entry ankle brace, comprising: (a) anelastomeric component defining an inside elbow channel configured tospan an ankle joint of a wearer, the elastomeric component having (i) adistal end portion comprising an arched foot portion configured toextend over and cover a top and opposite sides of a mid-foot of thewearer, (ii) a proximal end portion comprising an arched leg portionconfigured to extend over and cover a front and sides of a lower portionof a leg of the wearer, and (iii) an intermediate portion extendingbetween the foot portion and leg portion and comprising an arched ankleportion configured to extend over and cover a front and sides of anankle joint of the wearer, (iv) wherein a channel opening extends alonga length of the elastomeric component from the distal end portion to theproximal end portion and enables the elastomeric component to bepositioned directly onto and cover the front and sides of the mid-foot,lower leg portion, and ankle joint of the wearer without passing themid-foot through the proximal end portion; (b) a first leg strap securedto a first rear edge of the channel opening in an area of the legportion and a second leg strap connected to a second rear edge of thechannel opening in the area of the leg portion, the first and second legstraps configured to removably attach to each other for tensioning thefirst and second rear edges toward one another and securing the legportion to the lower leg of the wearer; and (c) a first foot strapextending from a first bottom edge of the channel opening an the area ofthe foot portion and a second foot strap extending from a second bottomedge of the channel opening in the area of the foot portion, each of thefirst and second leg straps configured (i) to span the channel openingin the area of the foot portion, and (ii) to removably attach to atleast one of the first and second leg straps when removably attached toeach other for tensioning the first and second bottom edges toward oneanother and securing the foot portion to the mid-foot of the wearer. 3.The brace of claim 2, wherein the first and second leg straps span thechannel opening between the first and second rear edges and overlap oneanother, and wherein the brace further comprises a slot along one of thefirst and second rear edges of the channel opening in the area of theleg portion through which one of the first and second leg strapsextends.
 4. The brace of claim 3, wherein the slot is defined by aD-ring that is at least partially embedded within the elastomericcomponent.
 5. The brace of claim 2, wherein the first and second footstraps extend diagonally upward from the first and second bottom edgesof the channel opening and cross over each other along the intermediateportion of the elastomeric component when the first and second footstraps are removably attached to at least one of the first and secondleg straps for tensioning the first and second bottom edges toward oneanother and securing the foot portion to the mid-foot of the wearer. 6.The brace of claim 2, wherein one of the first and second foot straps isa lower foot strap that extends under the other of the first and secondfoot straps that is an upper foot strap, the lower foot strap forming aplantar surface of the brace when spanning the channel opening in thearea of the foot portion.
 7. The brace of claim 6, wherein the upperfoot strap extends through a slot along one of the first and secondbottom edges of the channel opening in the area of the foot portion. 8.The brace of claim 7, wherein the slot is defined by a D-ring that is atleast partially embedded within the elastomeric component.
 9. Arear-entry ankle brace, comprising: (a) an elastomeric componentdefining an inside elbow channel configured to span an ankle joint of awearer, the elastomeric component having (i) a distal end portioncomprising an arched foot portion configured to extend over and cover atop and opposite sides of a mid-foot of the wearer, (ii) a proximal endportion comprising an arched leg portion configured to extend over andcover a front and sides of a lower portion of a leg of the wearer, and(iii) an intermediate portion extending between the foot portion and legportion and comprising an arched ankle portion configured to extend overand cover a front and sides of an ankle joint of the wearer, (iv)wherein a channel opening extends along a length of the elastomericcomponent from the distal end portion to the proximal end portion andenables the elastomeric component to be positioned directly onto andcover the front and sides of the mid-foot, lower leg portion, and anklejoint of the wearer without passing the mid-foot through the proximalend portion; (b) a leg strap secured to a rear edge of the channelopening in an area of the leg portion and configured to attach to asecond rear edge of the channel opening in the area of the leg portionremovably attach to itself for tensioning the first and second rearedges toward one another and securing the leg portion to the lower legof the wearer. (c) a first foot strap secured to and extending from afirst bottom edge of the channel opening in an area of the foot portionand a second foot strap secured to and extending from a second bottomedge of the channel opening in the area of the foot portion, each of thefirst and second leg straps configured (i) to span the channel openingin the area of the foot portion, and (ii) to removably attach to the legstrap for tensioning the first and second bottom edges toward oneanother and securing the foot portion to the mid-foot of the wearer. 10.The brace of claim 9, wherein the leg strap twice spans the channelopening between the first and second rear edges and overlaps itself, andwherein the brace further comprises a slot along one of the first andsecond rear edges of the channel opening in the area of the leg portionthrough which the leg strap extends.
 11. The brace of claim 10, whereinthe slot is defined by a D-ring that is at least partially embeddedwithin the elastomeric component.
 12. The brace of claim 9, wherein thefirst and second foot straps extend diagonally upward from the first andsecond bottom edges of the channel opening and cross over each otheralong the intermediate portion of the elastomeric component when thefirst and second foot straps are removably attached to the leg strap fortensioning the first and second bottom edges toward one another andsecuring the foot portion to the mid-foot of the wearer.
 13. The braceof claim 9, wherein one of the first and second foot straps is a lowerfoot strap that extends under the other of the first and second footstraps that is an upper foot strap, the lower foot strap forming aplantar surface of the brace when spanning the channel opening in thearea of the foot portion.
 14. The brace of claim 13, wherein the upperfoot strap extends through a slot along one of the first and secondbottom edges of the channel opening in the area of the foot portion. 15.The brace of claim 14, wherein the slot is defined by a D-ring that isat least partially embedded within the elastomeric component.
 16. Thebrace of claim 9, wherein each said strap is removably attached toanother said strap using hook and loop fasteners.
 17. (canceled)
 18. Thebrace of any of claim 9, wherein the elastomeric component consists of asingle molded piece of one or more thermoplastic materials.
 19. Thebrace of any of claim 9, wherein the elastomeric component furtherdefines on each of opposite lateral and medial sides of the brace acentral hub with radiating struts extending from the central hub andwith interstitial areas extending between the radiating struts.
 20. Thebrace of claim 19, wherein the interstitial areas comprising areas thatare substantially thinner than the radiating struts and that includeperforations extending through the elastomeric component forbreathability of the brace when worn. 21-31. (canceled)